New guidance on bioburden characterization for radiation-sterilized products in 11137-1
Martell Winters1, John Kowalski2, Chris Hardman3.
1Global Science Team, Nelson Laboratories, Salt Lake, UT, United States; 2Independent Consultant, Independent Consultant, New Jersey, NJ, United States; 3Bioburden/Radiation Department, Nelson Laboratories, Salt Lake, UT, United States
As a result of industry discussions, new requirements and guidance on bioburden characterization will be added to the new version of ISO 11137-1, particularly in 7.2 and A.7.2. This presentation will provide a summary of the additions and include the science behind its importance, as well as options on demonstrating compliance.
